EVOLVE II QCA: A Prospective, Multicenter Trial to Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s)

NCT ID: NCT01787799

Last Updated: 2016-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-10-31

Brief Summary

The purpose of this study is to evaluate 9 month angiographic and intravascular ultrasound (IVUS) data for the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System) in the treatment of subjects with atherosclerotic lesion(s) ≤34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).

Conditions

Atherosclerotic Lesion(s)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SYNERGY Stent System

SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)

Group Type: EXPERIMENTAL

SYNERGY

Intervention Type: DEVICE

Synergy is a device/drug combination product composed of two components, a device (coronary stent system including a chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating.

Interventions

SYNERGY

Synergy is a device/drug combination product composed of two components, a device (coronary stent system including a chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subject must be at least 18 years of age
• Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed
• For subjects less than 20 years of age enrolled at a Japanese site, the subject and the subject's legal representative must provide written informed consent before any study-specific tests or procedures are performed
• Subject is eligible for percutaneous coronary intervention (PCI)
• Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia
• Subject is an acceptable candidate for coronary artery bypass grafting (CABG)
• Subject is willing to comply with all protocol-required follow-up evaluation

• Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.25 mm and ≤4.0 mm
• Target lesion(s) length must be ≤34 mm (by visual estimate)
• Target lesion(s) must have visually estimated stenosis ≥50% and <100% with thrombolysis in Myocardial Infarction (TIMI) flow >1 and one of the following (stenosis ≥70%, abnormal fractional flow reserve (FFR), abnormal stress or imaging stress test, or elevated biomarkers prior to the procedure)
• Coronary anatomy is likely to allow delivery of a study device to the target lesions(s)
• The first lesion treated must be successfully pre-dilated/pretreated

Exclusion Criteria

• Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation MI (STEMI)
• Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina
• Subject has received an organ transplant or is on a waiting list for an organ transplant
• Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
• Planned PCI (including staged procedures) or CABG after the index procedure
• Subject previously treated at any time with intravascular brachytherapy
• Subject has a known allergy to contrast (that cannot be adequately premedicated) and/or the trial stent system or protocol-required concomitant medications (e.g., platinum, platinum-chromium alloy, stainless steel, everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors (clopidogrel, ticlopidine, prasugrel, or ticagrelor), or aspirin)
• Subject has one of the following (as assessed prior to the index procedure):

• Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 24 months
• Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.)
• Planned procedure that may cause non-compliance with the protocol or confound data interpretation
• Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin, coumadin) for indications other than acute coronary syndrome
• Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3
• Subject has a white blood cell (WBC) count < 3,000 cells/mm3
• Subject has documented or suspected liver disease, including laboratory evidence of hepatitis
• Subject is on dialysis or has baseline serum creatinine level >2.0 mg/dL (177µmol/L)
• Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
• Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months
• Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding
• Subject has severe symptomatic heart failure (i.e., New York Heart Association (NYHA) class IV)
• Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint
• Subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure
• Subject with known intention to procreate within 12 months after the index procedure (women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure)
• Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential)

Planned treatment of more than 3 lesions

• Planned treatment of lesions in more than 2 major epicardial vessels
• Planned treatment of a single lesion with more than 1 stent
• Subject has 2 target lesions in the same vessel that are separated by less than 15 mm (by visual estimate)
• Target lesion(s) is located in the left main
• Target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate.
• Target lesion(s) is located within a saphenous vein graft or an arterial graft
• Target lesion(s) will be accessed via a saphenous vein graft or arterial graft
• Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
• Target lesion(s) treated during the index procedure that involves a complex bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent)
• Target lesion(s) is restenotic from a previous stent implantation or study stent would overlap with a previous stent
• Subject has unprotected left main coronary artery disease (>50% diameter stenosis)
• Subject has been treated with any type of PCI (i.e., balloon angioplasty, stent, cutting balloon atherectomy) within 24 hours prior to the index procedure
• Thrombus, or possible thrombus, present in the target vessel (by visual estimate)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Medstar Health Research Institute

OTHER

Sponsor Role: collaborator

Quintiles, Inc.

INDUSTRY

Sponsor Role: collaborator

Medidata Solutions

INDUSTRY

Sponsor Role: collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ian Meredith, Professor

Role: PRINCIPAL_INVESTIGATOR

Monash Medical Centre-Clayton Campus, 246 Clayton Road, 3168 Clayton, Victoria, Australia

Locations

The Prince Charles Hospital

Chermside, Queensland, Australia

Monash Medical Centre-Clayton Campus

Clayton, Victoria, Australia

St Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

Fremantle Hospital

Fremantle, Western Australia, Australia

Shonan Kamakura General Hospital

Kamakura-shi, Kanagawa, Japan

Mercy Angiography Unit, Ltd.

Auckland, , New Zealand

Auckland City Hospital

Auckland, , New Zealand

Ascot Angiography Ltd

Auckland, , New Zealand

Middlemore Hospital

Auckland, , New Zealand

North Shore Hospital

Auckland, , New Zealand

Christchurch Hospital NZ

Christchurch, , New Zealand

National University Hospital

Singapore, , Singapore

National Heart Centre

Singapore, , Singapore

Countries

Australia; Japan; New Zealand; Singapore

Other Identifiers

S2072

Identifier Type: -

Identifier Source: org_study_id